MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number 1012492-23

Device Problems Positioning Failure (1158); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.The investigation determined the reported balloon rupture and failure to deploy stent appears to be related to circumstances of the procedure.It should be noted that the absorb, instructions for use (ifu) states: it is not recommended to treat patients having a lesion that prevents complete inflation of an angioplasty balloon, or a lesion with greater than 40% residual stenosis after predilatation by visual estimation.A review of the lot history record (lhr) revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.It should be noted that the ifu, instructs the physician to: note the product use-by (expiration) date on the package.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The absorb device is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.

Event Description

It was reported that the procedure was to treat a heavily calcified lesion in the mid left anterior descending (lad) artery.Pre-dilatation was done, but due to the calcification, the lesion could not be optimally prepped and more than 40% residual stenosis remained.The 2.5 x 23 mm absorb was advanced to the lesion, but the balloon ruptured during first inflation at nominal pressure.The delivery catheter was removed with the stent still crimped on the balloon.The procedure was successfully completed with a non-abbott drug eluting stent.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6378282
• MDR Text Key: 69269109
• Report Number: 2024168-2017-01791
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648183768
• UDI-Public: (01)08717648183768(17)161123(10)5052961
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2016
• Device Catalogue Number: 1012492-23
• Device Lot Number: 5052961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 70