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

Catalog Number 1012464-18

Device Problems Peeled/Delaminated (1454); Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2014

Event Type  malfunction  

Event Description

It was reported that using a radial access site, pre-dilatation was performed; however, the 3.5x18 mm device did not cross.There was a little bit of resistance upon removal as the struts were a bit flared.Three additional devices (3.0x18 mm, 3.0x28 mm and 3.0x18 mm) crossed the lesion without any additional pre-dilatation or other procedural changes.There was no clinically significant delay in the procedure and no adverse patient effects.Return device analysis revealed balloon material peeling.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation.The reported flared struts were not confirmed.However, balloon peeling was observed.The failure to advance and difficulty to remove/vessel resistance could not be replicated in a testing environment as it was based on operational circumstances.Based on visual and dimensional analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to this complaint.A query of the electronic complaint handling database revealed no other incidents for failure to advance, difficult to remove or damage reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.Though the device is not approved for sale in the u.S., it uses a delivery system which is similar to a device sold in the u.S.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3913838
• MDR Text Key: 4671442
• Report Number: 2024168-2014-04357
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2014
• Device Catalogue Number: 1012464-18
• Device Lot Number: 3121161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2014
• Initial Date FDA Received: 07/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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