MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-10-29 for MEDPOR IMPLANT 89020 manufactured by Porex Surgical.
[1669482]
It was reported that during a percutaneous coronary intervention (pci) procedure, a balloon rupture occurred. Access was obtained through the femoral artery. The 90% stenotic, de novo lesion was located in the moderately tortuous and severely calcified proximal left anterior descending artery. It was noted that resistance was met during insertion of the 2. 25x15mm maverick2 balloon. The physician advanced the balloon to the lesion and on an unspecified inflation, the balloon was inflated to 6atms and the balloon ruptured. The device was removed intact. The procedure was completed with a different device. No complications were reported and the patient's status is good.
Patient Sequence No: 1, Text Type: D, B5
[8899942]
The doctor reported that the medpor left cranial implant was explanted on (b)(6), 2010. The doctor reported that the patient is doing well. No other implant was placed after the surgery. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[17894134]
The doctor reported that the patient has an infection and will need another customized implant.
Patient Sequence No: 1, Text Type: D, B5
[17981403]
The device history records for lot number 89020-mci-019-08 (b)(4) was reviewed and all processes and test parameters were within the medpor implant specification. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2010-00039 |
| MDR Report Key | 1886422 |
| Report Source | 05 |
| Date Received | 2010-10-29 |
| Date of Report | 2010-11-15 |
| Date of Event | 2010-10-20 |
| Date Mfgr Received | 2010-10-29 |
| Device Manufacturer Date | 2008-01-31 |
| Date Added to Maude | 2010-11-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. KENT IVERSEN |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 302651017 |
| Manufacturer Country | US |
| Manufacturer Postal | 302651017 |
| Manufacturer Phone | 6784791611 |
| Manufacturer G1 | POREX SURGICAL |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 30265101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30265 1017 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDPOR IMPLANT |
| Generic Name | MEDPOR CUSTOMIZED SURGICAL IMPLANT |
| Product Code | JOF |
| Date Received | 2010-10-29 |
| Model Number | NA |
| Catalog Number | 89020 |
| Lot Number | MCI-019-08 D009A10H |
| ID Number | 510K# K083621 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART ROAD NEWNAN GA 30265101 US 30265 1017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-10-29 |