MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number	1235300-28
Health Effect - Clinical Code	Perforation (2001)
Date of Event	10/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient effect of perforation, as listed in the absorb gt1 instructions for use is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure; however, a conclusive cause for the reported perforation cannot be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The graftmaster 2.8 x 19 referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the moderately tortuous and moderately calcified distal left anterior descending coronary artery was predilated with laser atherectomy.After post dilatation of the 3.0x28 absorb gt1 was performed, a perforation was noted.The 2.8x19 graftmaster stent delivery system (sds) was inserted, but unable to advance past the tortuous and calcified anatomy and the newly implanted gt1.Subsequent to the device interaction, the proximal shaft of the graftmaster sds separated.The guide catheter, guide wire, and sds were removed together as a unit.A new graftmaster sds was inserted to successfully cross the gt1 and treat the perforation.There was no adverse patient sequela.No additional information was provided.

• Brand Name: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Common Device Name: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6110825
• Report Number: 2024168-2016-08050
• Device Sequence Number: 16330488
• Product Code: PNY
• UDI-Device Identifier: 08717648213069
• UDI-Public: (01)08717648213069(17)170711(10)6071261
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P150023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/11/2017
• Device Catalogue Number: 1235300-28
• Device Lot Number: 6071261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2016
• Initial Report FDA Received Date: 11/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 86